FDA applicant
Neko Health AB
FDA records 3 decisions for Neko Health AB (Danderyd, SE) in 2026: 3 510(k) clearances. Most are in product codes LHQ (System, Telethermographic (Adjunctive Use)) and MUD (Oximeter, Tissue Saturation). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neko Health AB’s devices, and how often a recall has named them.
FDA decisions per year
3in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Neko Health AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report